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EUDAMED last updated this device on Mar 15, 2024
B-05904365620147Papain ST is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — Annex II List A. Manufactured by Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach. Placed on the EU market in Poland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
05904365620147107(01)05904365620147
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0103030307ENZYMES (E.G. BROMELIN / PAPAIN, ETC.)PL-MF-0000376421434-IVDD-160/20221434-IVDD-159/2022Primary placement in Poland; available across 1 country total.
Placed on the market in Poland; per-country availability dates not published.
Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
View in glossary →Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
View in glossary →UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
View in glossary →IVDR risk classes
IVDR risk classes rank in-vitro diagnostic devices from lowest risk (Class A) to highest (Class D), based on the patient and public-health risk of a wrong result.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →No certificate specifically references this device's Basic UDI-DI.
No certificates registered for this manufacturer.
No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.B-05904365620246On the marketLISS - L Low ionic strenght salt solution5904365620LISSL97On the marketLISS-M (low ionic strength solution medium) is a salt solution with low ionic strength, standardised pH and osmolality values. LISS-M reagent is used for washing and preparing red cell suspensions for in vitro immunohaematology tests.5904365620LISSM99On the marketPBS – buffered salt solution pH 6,9 (5 liters)5904365620PBSBLOn the marketPBS buffered salt solution pH 6,9 (2liters)5904365620PBSBLOn the marketPBS zbuforowany fizjologiczny roztwór soli do badań serologicznych pH 6,95904365620PBSBLOn the market